Hydralazine Hydrochloride

Product NDC
63629-8497
11-digit product format
636298497
Labeler code
63629
Product ID
63629-8497_0a3f1261-d3e3-4f67-9a28-01edbf99635e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205236
Marketing category
ANDA
Marketing start
2017-05-26
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
FD171B778YHYDRALAZINE HYDROCHLORIDE304-20-1HYDRALAZINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-8497-1636298497011000 TABLET in 1 BOTTLE (63629-8497-1) 1000 tablet2021-05-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HydrALAZINE Hydrochloride Tablets USPBryant Ranch Prepack2024-01-11HUMAN PRESCRIPTION DRUG LABEL102